Forceps for medical use

ABSTRACT

Forceps having two-half shells are disclosed. Each half-shell includes a front rim and a base wall and is mounted on a support element in a manner such that the half-shells can adopt a first opened-out configuration and a second closed configuration. The forceps include at least one container element having a cavity for receiving a plurality of biopsy samples. The container element is preferably associated with one of the half-shells.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 10/111,372, filed Sep. 10, 2002, now pending, which is a national stage of PCT International Application No. 01/PCT/IB00/01532 A1, filed Oct. 24, 2000, now abandoned, and claims priority to Italian Application No. CE99A000004, filed Oct. 25, 1999, the entirety of all of which are incorporated herein by reference.

The present invention relates to forceps for medical use, in particular for biopsy, for example, for endoscopic biopsy, laparoscopy, gynaeocological applications and the like.

More specifically, a conventional forceps of this type comprises two half-shells, each of which has a front rim and a base wall, and which are mounted on a support element in a manner such that they can adopt a first, opened-out configuration and a second, closed configuration.

In use, for example, during digestive endoscopy, the forceps is passed through the operating duct of an endoscope in the closed configuration and is brought into contact with the internal mucosa of the organ (for example, the oesophagus, stomach, duodenum, or colon) to be biopsied.

Once the forceps has been positioned correctly, the half-shells are opened and then closed so as to cut off a sample of the mucosa which remains held between them. Given the intrinsically limited nature of the space available, the closed half-shells can hold at most 2-3 biopsy samples.

However, pathological conditions frequently occur in which the number of samples taken has to be greater, as with gastric ulcers, or dysplasia or neoplasia in ulcerative pancolitis, which is a serious chronic disease of the colon.

In these cases, each time the space inside the half-shells is filled with biopsy samples, the forceps has to be withdrawn through the endoscope duct, emptied and reintroduced to the operation site. A large amount of wear and deformation of the duct thus takes place, with the risk of rupture and consequent infiltration of liquid which may cause very serious damage to the endoscope.

Another problem connected with the need to perform a plurality of introductions and withdrawals of the forceps consists of the long duration of this procedure which is due, among other things, to the need to empty the half-shells. Owing to the small size of the samples taken, this operation in fact takes the operator a considerable amount of time. In operative practice, however, the time available -in certain conditions, for example, with markedly intolerant patients who are unable to take sedatives-may be very limited, so that the use of conventional forceps is difficult.

To prevent the problems of the prior art mentioned above, the subject of the present invention is forceps of the type described at the beginning of the present description and characterized in that it has at least one container element having a cavity for receiving a plurality of biopsy samples.

The forceps of the invention can therefore be used to take all of samples necessary for a given pathological condition, in succession, by performing only one introduction and withdrawal, thus considerably reducing the time required for the operation, as well as the wear of the endoscope duct.

Moreover, during the withdrawal stage, the container element keeps the biopsy samples isolated from the duct, which has the advantage of preventing any mixing with impurities or with any scraps remaining from other samples taken, which may be present therein.

Further advantages and characteristics of the present invention will become clear from the following detailed description, provided by way of non-limiting example with reference to the appended drawings, in which:

FIG. 1 is a schematic plan view of a forceps of the invention,

FIG. 2 is a front elevational view of the forceps of FIG. 1,

FIG. 3 is a section view taken on the line III-III of FIG. 1,

FIGS. 4 and 5 are respective plan views of each of the two half-shells of a forceps constituting an alternative embodiment of the invention,

FIG. 6 is a section taken on the line VI-VI of FIG. 4,

FIG. 7 is a section view taken on the line VII-VII of FIG. 5, and

FIGS. 8 and 9 are views corresponding to FIGS. 5 and 7, respectively, of a further embodiment of a detail of a forceps of the invention.

A biopsy forceps, for example, for endoscopic biopsy, comprises (FIGS. 1-3) two half-shells 10 a, 10 b each having a front rim 12 and a base wall 14. The half-shells 10 a, 10 b are mounted in conventional manner, for example, on a support element 16 so that they can adopt a first, opened-out configuration (shown in the drawings) and a second, closed configuration in which the rims 12 of the two half-shells 10 a, 1 b are in contact with one another.

The half-shell 10 b has, in its base wall 14, a hole 18 which communicates with the cavity 20 inside a beaker-shaped container element 22 associated therewith and having a plurality of through-openings 24 in its walls.

The material constituting the element 22 is not critical within the scope of the present invention and may be selected, without particular limitations, from those suitable for use in the medical field.

The half-shell 10 a, on the other hand, is filled up to approximately a third of its height with filling material 25.

In use, the forceps is first of all passed through an endoscope duct (not shown in the drawings), with the half-shells 10 a, 10 b in the closed configuration, until the forceps is in the desired location close to the internal mucosa of the organ to be biopsied. Here, the half-shells 10 a, 10 b are opened out and closed again several times in succession so as to cut off a corresponding number of biopsy samples.

As these samples are taken one by one, they are urged towards the base of the container element 22 by the pressure exerted by the half-shell 10 a.

The openings 24 allow air and any organic liquids which remain trapped in the cavity 20 of the element 22 to be discharged, further facilitating the movement of the biopsy samples inside the element 22.

Upon completion of the cutting of the samples, the half-shells 10 a, 10 b are closed again and the forceps, with its container element 22, can be withdrawn through the endoscope duct. The biopsy samples which are enclosed inside the cavity 20 do not therefore have any substantial contact with the duct, which could constitute a potential source of histological contamination.

FIGS. 4 to 7 show an alternative embodiment of the half-shells of a biopsy forceps according to the invention, which half-shells can be mounted on a support element in a manner similar to that described with reference to FIGS. 1-3.

In this embodiment, the half-shell 10 a with which the container element 20 is not associated has (FIGS. 4 and 6) a base wall 14 having a central portion 26 which is raised substantially to the level of the rim 12, and an annular, recessed, peripheral portion 28.

The half-shell 10 b, on the other hand, (FIGS. 5 and 7) has, in its base wall 14, the hole 18 in which the end of the beaker-shaped container element 22 is fixed by means of an annular layer of adhesive 30, this end being open and having a restricted neck. The internal cavity 20 of the container element 22 thus constitutes a continuation of the space inside the half-shell 10 b.

The container element 22 also has openings 24 in its base and side walls.

The principle of the operation of the forceps having the half-shells just mentioned is substantially similar to that described with reference to FIGS. 1-3. The particular shape of the half-shell 10 a enables a greater pressure to be exerted on the biopsy samples, directing them towards the cavity 20 of the element 22.

FIGS. 8 and 9 show a variant of the fixing of the container element 22 to the half-shell 10 b, which is an alternative to the use of the above-described layer of adhesive. In this case, the open end of the element 22 has a hooked rim for engaging a rim of complementary shape of the hole 18 of the half-shell 10 b. This engagement is preferably secured by a mechanical element such as a spring ring 32.

Naturally, the principle of the invention remaining the same, the details of construction and forms of embodiment may be varied widely with respect to those described purely by way of example, without thereby departing from its scope. In particular, both of the half-shells may have their own container elements and/or may have, independently of one another, any shape, for example, with a toothed or serrated rim. The container element in turn may have substantially any shape and/or length and/or may be in the form of a net engaged directly on the rim of the associated half-shell. Moreover, the container element may equally well be secured on the respective half-shell immovably, or releasably. 

1-10. (canceled)
 11. A medical device, comprising: a first and a second half-shell, each having a front rim and a base wall, the first and the second half-shells each being mounted on a support element in a manner such that the first and the second half-shells can adopt a first, open configuration and a second, closed configuration, the first half-shell including a hole in the base wall configured to pass a biopsy sample; and a container element associated with the first half-shell, the container element having an open end for receiving the biopsy sample into a cavity sized to contain a plurality of biopsy samples, the open end corresponding in size to the hole in the base wall of the first half-shell, wherein the first half-shell and the second half-shell have different configurations.
 12. The medical device of claim 11, wherein the hole communicates with the cavity of the container element associated with the first half-shell.
 13. The medical device of claim 11, wherein the container element is beaker-shaped and is fixed in the hole such that the cavity constitutes a continuation of a space inside the first half-shell.
 14. The medical device of claim 11, wherein the open end of the container element is fixed to the first half-shell by an annular layer of adhesive.
 15. The medical device of claim 11, wherein the open end of the container element includes a hooked rim for engaging the front rim of the first half-shell.
 16. The medical device of claim 15, wherein the engagement of the hooked rim of the open end of the container element with the front rim of the hole of the first half-shell is secured by a mechanical element.
 17. The medical device of claim 11, wherein the container element is beaker-shaped and includes a container base and side walls, and has at least one opening in the container base or in the side walls.
 18. The medical device of claim 17, wherein the container element has a plurality of openings in the container base and in the side walls.
 19. The medical device of claim 15, wherein the front rim of the first half-shell is a complementary shape of the hooked rim of the container element.
 20. The medical device of claim 16, wherein the mechanical element is a spring ring.
 21. The medical device of claim 11, wherein at least a portion of the container element is completely encircled by the base wall of the first half-shell.
 22. The medical device of claim 11, wherein the hole is configured to pass the plurality of biopsy samples therethrough.
 23. The medical device of claim 11, wherein the first and second half-shells are configured so that the front rims come into contact with each other when in the closed configuration.
 24. The medical device of claim 11, wherein the first and second half-shells are configured to take biopsy samples.
 25. The medical device of claim 11, wherein the container element includes an opening for discharging fluid from the cavity.
 26. A method of taking multiple biopsy samples, comprising: providing a medical device having a first half-shell, a second half-shell having a configuration different from the first half-shell, and a container element; closing the first and second half-shells to take a first biopsy sample of a body organ, the first biopsy sample moving through a hole in the first half-shell, through an open end of the container element, and into a cavity of the container element; opening the first and second half-shells; and closing the first and second half-shells to take a second biopsy sample without removing the medical device from the body organ, the second biopsy sample moving through the hole in the first half-shell, through the open end of the container element, into the cavity of the container element.
 27. The method of claim 26, wherein the second biopsy sample urges the first biopsy sample further away from the hole in the first half-shell.
 28. The method of claim 26, wherein the container element defines an opening at an end substantially opposite to the open end, the open end located closest to the hole in the first half-shell.
 29. The method of claim 26, wherein the container element defines a plurality of side openings.
 30. The method of claim 26, wherein the second half-shell urges the first and second biopsy samples through the hole of the first half-shell.
 31. The method of claim 26, wherein the open end of the container element is substantially surrounded by one of the first half-shell and the second half-shell.
 32. The method of claim 28, further comprising removing air or liquid from the container element via the opening.
 33. The method of claim 29, further comprising removing air or liquid from the container element via the plurality of side openings.
 34. The method of claim 26, wherein at least a portion of the container element is disposed in the hole of the first half-shell.
 35. The method of claim 26, wherein at least one of the first half-shell and the second half-shell define a sharp edge.
 36. The method of claim 26, wherein the second half-shell includes a raised portion disposed radially inward from an outer periphery of the second half-shell.
 37. The method of claim 26, further comprising closing the first and second half-shells to take a third biopsy sample without removing the medical device from the body organ, the third biopsy sample moving through the hole in the first half-shell, through the open end of the container element, into the cavity of the container element.
 38. The method of claim 37, wherein the third biopsy sample urges the first and second biopsy samples further away from the hole in the first half-shell.
 39. The method of claim 26, further comprising preventing the first and second biopsy samples from contacting the body organ.
 40. The method of claim 26, further comprising inserting the medical device through an endoscope duct.
 41. The method of claim 40, wherein the first and second half-shells take the first and second biopsy samples without removing the medical device from the endoscope duct. 